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2020-02-04 FDA

FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

FDA在冠状病毒应对措施上迈出了重要的一步，发布首个2019年新型冠状病毒诊断的紧急使用授权

Today, the U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.

今天，美国FDA签发了紧急使用授权（EUA），以实现对美国疾病预防中心(CDC) 2019-nCoV实时RT-PCR诊断系统的更广泛的紧急使用。迄今为止，该检测仅限于CDC实验室使用。今天的授权书允许在全国任何CDC认证的实验室中使用该检测。

“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen M. Hahn, M.D. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”

FDA 局长Stephen M. Hahn博士表示：“自疫情首次出现以来，我们一直与我们在美国政府和全球各地的合作伙伴紧密合作，加快关键医疗产品的开发和可及性，帮助尽快结束疫情。这仍然是一种不断演变的局势，将这种诊断检测分发给合格实验室的能力是保护公共卫生的关键一步。我们与CDC的合作对迅速研发和便利获得这种诊断检测至关重要。FDA仍然坚定地致力于利用我们的监管工具、技术和科学专长，促进关键医疗产品的可及性，以尽可能最快、安全和有效的方式应对此次疫情。”

The 2019-novel coronavirus (2019-nCoV), identified in Wuhan, China in December 2019, is a new type of coronavirus that can cause severe respiratory illness in humans. Most patients with confirmed 2019-nCoV infection have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with 2019-nCoV infection. To date most reported cases of 2019-nCoV infection outside of China have been linked to residence in or travel to Wuhan, China. At this time, federal health officials continue to believe that the threat to the general American population from this virus is relatively low.

2019年12月在中国武汉发现的新型冠状病毒(2019- ncov)是一种新型冠状病毒，可导致人类严重的呼吸道疾病。大多数确诊为2019-nCoV感染的患者出现发烧和/或急性呼吸系统疾病症状（例如，咳嗽，呼吸困难）。但是，目前尚缺乏足够的信息来表征与2019-nCoV感染相关的全部临床疾病。迄今为止，大多数在中国境外报告的2019-nCoV感染病例都与在中国武汉居住或旅行有关。这时，联邦卫生官员仍然认为，这种病毒对美国普通民众的威胁相对较小。

Under this EUA, the use of 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests. The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.

根据该EUA， 2019-nCoV实时RT-PCR诊断系统被授权用于符合CDC 2019-nCoV检测标准的患者。检测仅限于CDC认证的实验室，在美国，这些实验室需要能够执行高复杂度检测以获得认证。诊断方法是逆转录酶聚合酶链反应(PCR)检测，该检测可从呼吸道分泌物(如鼻腔或口腔拭子)中检测2019-nCoV。阳性测试结果表明可能感染了2019-nCoV，被感染的患者应与医疗保健提供者合作以控制症状并确定如何最好地保护周围的人。阴性结果并不排除2019-nCoV感染，也不应作为治疗或其他患者管理决策的唯一依据。阴性结果必须与临床观察、患者病史和流行病学信息相结合。

The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing such disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.

FDA可以基于科学数据签发EUA，以在卫生与人类服务部（HHS）确定出现公共卫生紧急情况或重大潜在公共卫生紧急情况并宣布当前情况可证明医药产品的紧急使用时，使用某些在诊断、治疗或预防此类疾病或状况时可能有效医疗产品，重大潜在公共卫生紧急情况是指对国家安全或美国公民的健康与安全有重大影响的情况。

On Jan. 31, HHS Secretary Alex Azar declared a public health emergency recognizing the potential threat that 2019-nCoV poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat. As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of 2019-nCoV it was determined that an EUA is crucial to ensure timely access to diagnostics. The HHS Secretary accordingly today made the necessary EUA determination and declaration and the FDA issued this EUA in response to a request from the CDC. This action is the result of the close collaboration between the FDA, the CDC and the Centers for Medicare and Medicaid Services, which provides oversight for U.S. laboratories, to prioritize the efficient development and implementation of critical medical products in response to emerging infectious disease outbreaks, such as novel coronavirus.

1月31日，HHS部长Alex Azar宣布公共卫生紧急情况，认识到2019-nCoV可能造成的威胁，并重申政府致力于利用所有可用资源来帮助预防、缓解和应对这种威胁。由于没有FDA批准用于检测2019-nCoV的商业化诊断检测方法，因此可以确定EUA对于确保及时获取诊断信息至关重要。HHS部长今天做出了必要的EUA决定和声明，并且FDA根据CDC的要求签发EUA。这项行动是FDA、CDC、医疗保险与救助中心之间密切合作的结果，为美国提供实验室监督、优先有效的开发和实现关键的医疗产品，以应对新兴传染病疫情，如新型冠状病毒。

The FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak on Jan. 27. The agency remains committed to working with developers, international partners and the U.S. government to help support this public health response. The FDA is dedicated to actively working with other 2019-nCoV diagnostic developers to help accelerate development programs and requests for EUAs, in fact several have already requested and received the EUA template for this outbreak. The FDA, among other steps, is providing its highest level of attention to helping expedite the development and review of a variety of medical products being developed to diagnose, treat and prevent the spread of this outbreak.

1月27日， FDA概述了可使用得所有适用的监管授权，加快关键医疗产品开发和可及性以预防、诊断和治疗2019-nCoV的方法，应对此次疫情。监管机构仍致力于与开发者、国际合作伙伴和美国政府合作，帮助支持这种公共卫生对策。FDA致力于与其他2019-nCoV诊断开发者积极合作，以帮助加快开发项目和EUA的要求，事实上，已有几家开发者针对此次疫情已经请求并收到了EUA模板。FDA正在提供最高级别的关注，以帮助加快开发和审查正在开发的各种医疗产品，以诊断、治疗和预防疫情的蔓延。

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Related Information

• FDA: Emergency Use Authorization

• FDA: Novel coronavirus (2019-nCOV)

• News Release: FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

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FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

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